Ostomy Belt Use Associated Quality of Life | NCT04715893

Studies
Ostomy Belt Use Associated Quality of Life

NCT04715893

Sponsor

University of Miami

Status

Completed

Last Update Posted

Jan 17, 2025Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Stoma Ileostomy
Stoma Colostomy

Interventions

Ostomy belt

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2021Actual

Primary Completion Date

Feb 28, 2024Actual

Completion Date

Feb 28, 2024Actual

First Submitted Date

Jan 14, 2021

First Submission Date that Met QC Criteria

Jan 14, 2021

First Posted Date

Jan 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2025

Last Update Posted Date

Jan 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to elucidate whether the use of an ostomy belt can improve the quality of life in patients with an ostomy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ostomy belt group	Experimental	Participants in this group will receive ostomy belts for eight weeks.	Other: Ostomy belt

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ostomy belt	Other	Stealth ostomy belt continuous for eight weeks	Ostomy belt group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in quality of life as measured by SQOLS	Quality of life will be assessed using the Stoma Quality of Life Scale questionnaire (SQOLS) with a range in score from 0 to 100 in overall satisfaction in life with a higher score indicating higher satisfaction.	Baseline to 4 weeks, baseline to 8 weeks post ostomy belt use

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Current patients at University of Miami Hospital with stoma willing to trial an ostomy belt
18 - 70 years old
Willing and able to sign informed consent

Exclusion Criteria:

Patients without stoma or unwilling to wear ostomy belt.
Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vanessa Hui, MD	University of Miami	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami		Miami	Florida	33136	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided